Trial Outcomes & Findings for A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients (NCT NCT01464190)
NCT ID: NCT01464190
Last Updated: 2014-04-01
Results Overview
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
659 participants
Primary outcome timeframe
Every 4 weeks from baseline to Week 28
Results posted on
2014-04-01
Participant Flow
Participant milestones
| Measure |
PA21
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
|
Sevelamer Carbonate
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
|---|---|---|
|
Overall Study
STARTED
|
391
|
268
|
|
Overall Study
COMPLETED
|
322
|
227
|
|
Overall Study
NOT COMPLETED
|
69
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
Baseline characteristics by cohort
| Measure |
PA21
n=391 Participants
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
Sevelamer Carbonate
n=268 Participants
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
Total
n=659 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 14.58 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 13.77 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
296 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
486 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
95 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
133 participants
n=7 Participants
|
287 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
85 participants
n=5 Participants
|
49 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
16 participants
n=5 Participants
|
8 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
65 participants
n=5 Participants
|
44 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
37 participants
n=5 Participants
|
18 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
32 participants
n=5 Participants
|
15 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 4 weeks from baseline to Week 28Population: For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Outcome measures
| Measure |
PA21
n=384 Participants
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
Sevelamer Carbonate
n=260 Participants
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
|---|---|---|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Week 4 (n = 346, 236)
|
-0.2 mg/dL
Standard Deviation 1.33
|
-0.1 mg/dL
Standard Deviation 1.47
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Week 8 (n = 325, 238)
|
-0.2 mg/dL
Standard Deviation 1.38
|
0.1 mg/dL
Standard Deviation 1.56
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Week 12 (n = 322, 242)
|
-0.0 mg/dL
Standard Deviation 1.43
|
0.2 mg/dL
Standard Deviation 1.55
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Week 16 (n = 313, 228)
|
0.0 mg/dL
Standard Deviation 1.57
|
0.2 mg/dL
Standard Deviation 1.75
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Week 20 (n = 300, 221)
|
-0.0 mg/dL
Standard Deviation 1.46
|
0.1 mg/dL
Standard Deviation 1.44
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Week 24 (n = 286, 208)
|
0.1 mg/dL
Standard Deviation 1.53
|
0.2 mg/dL
Standard Deviation 1.78
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Chnage from Baseline to Week 28 (n = 287, 210)
|
0.2 mg/dL
Standard Deviation 1.52
|
0.2 mg/dL
Standard Deviation 1.76
|
|
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Change from Baseline to Endpoint (n = 384, 260)
|
0.1 mg/dL
Standard Deviation 1.62
|
0.3 mg/dL
Standard Deviation 1.79
|
PRIMARY outcome
Timeframe: Every 4 weeks from baseline to Week 28Population: For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Outcome measures
| Measure |
PA21
n=384 Participants
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
Sevelamer Carbonate
n=260 Participants
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
|---|---|---|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 4 (n = 346, 236
|
-1.2 mg/dL
Standard Deviation 12.07
|
-0.8 mg/dL
Standard Deviation 13.37
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 8 (n = 325, 238)
|
-1.2 mg/dL
Standard Deviation 12.30
|
1.5 mg/dL
Standard Deviation 14.40
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 12 (n = 321, 242)
|
0.1 mg/dL
Standard Deviation 12.94
|
1.9 mg/dL
Standard Deviation 13.79
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 16 (n = 313, 228)
|
0.5 mg/dL
Standard Deviation 14.04
|
2.0 mg/dL
Standard Deviation 16.05
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 20 (n = 300, 221)
|
0.4 mg/dL
Standard Deviation 13.24
|
1.6 mg/dL
Standard Deviation 13.29
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 24 (n = 284, 207)
|
1.1 mg/dL
Standard Deviation 13.57
|
2.2 mg/dL
Standard Deviation 15.74
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Week 28 (n = 286, 210)
|
2.3 mg/dL
Standard Deviation 13.52
|
2.3 mg/dL
Standard Deviation 16.39
|
|
Change From Baseline and Levels at Each Time Point for Serum Calcium
Change from Baseline to Endpoint (n = 365, 258)
|
1.5 mg/dL
Standard Deviation 13.86
|
2.9 mg/dL
Standard Deviation 16.68
|
PRIMARY outcome
Timeframe: Every 4 weeks from baseline to Week 28Population: For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.
Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.
Outcome measures
| Measure |
PA21
n=384 Participants
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
Sevelamer Carbonate
n=260 Participants
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
|---|---|---|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 4 (n = 365, 252)
|
11.8 pg/mL
Standard Deviation 177.39
|
25.9 pg/mL
Standard Deviation 186.42
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 8 (n = 362, 258)
|
8.6 pg/mL
Standard Deviation 204.39
|
40.8 pg/mL
Standard Deviation 201.18
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 12 (n = 352, 252)
|
28.9 pg/mL
Standard Deviation 315.81
|
64.1 pg/mL
Standard Deviation 204.11
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 16 (n = 341, 241)
|
54.5 pg/mL
Standard Deviation 352.92
|
52.3 pg/mL
Standard Deviation 210.35
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 20 (n = 334, 236)
|
28.0 pg/mL
Standard Deviation 233.13
|
72.1 pg/mL
Standard Deviation 228.03
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 24 (n = 320, 226)
|
27.7 pg/mL
Standard Deviation 271.31
|
79.6 pg/mL
Standard Deviation 253.65
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Week 28 (n = 310, 222)
|
53.0 pg/mL
Standard Deviation 287.19
|
71.5 pg/mL
Standard Deviation 278.03
|
|
Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Change from Baseline to Endpoint (n = 381, 260)
|
52.3 pg/mL
Standard Deviation 273.14
|
67.5 pg/mL
Standard Deviation 270.06
|
Adverse Events
PA21
Serious events: 78 serious events
Other events: 208 other events
Deaths: 0 deaths
Sevelamer Carbonate
Serious events: 52 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PA21
n=391 participants at risk
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
Sevelamer Carbonate
n=267 participants at risk
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
|---|---|---|
|
Surgical and medical procedures
Abdominal operation
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
1.1%
3/267 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Angina unstable
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Arterial stenosis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Arterial thrombosis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Arteriosclerosis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Surgical and medical procedures
Arteriovenous graft
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
1.1%
3/267 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Bacteraemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Bradycardia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.77%
3/391 • Number of events 4
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Catheter site infection
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Cellulitis
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.77%
3/391 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
General disorders
Chest pain
|
0.77%
3/391 • Number of events 4
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.77%
3/391 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Convulsion
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
General disorders
Device occlusion
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Diabetic foot
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Diverticulitis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Erysipelas
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Eye disorders
Eye haemorrhage
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.0%
4/391 • Number of events 5
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
2.2%
6/267 • Number of events 6
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Gangrene
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Graft infection
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Haematoma
|
1.0%
4/391 • Number of events 4
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Haemorrhage
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Investigations
International normalised ratio increased
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Ischaemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Left ventricular failure
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Lobar pneumonia
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Localised infection
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
General disorders
Medical device complication
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.26%
1/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Orchitis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Osteomyelitis
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Peritonitis
|
0.77%
3/391 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Peritonitis bacterial
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Pneumonia
|
1.5%
6/391 • Number of events 6
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
2.2%
6/267 • Number of events 6
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
1.1%
3/267 • Number of events 4
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage IV
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Sepsis
|
0.77%
3/391 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.75%
2/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Thrombophlebitis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
General disorders
Thrombosis in device
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Investigations
Troponin increased
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.51%
2/391 • Number of events 2
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.77%
3/391 • Number of events 3
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/391
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.37%
1/267 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Infections and infestations
Wound infection
|
0.26%
1/391 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
0.00%
0/267
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
Other adverse events
| Measure |
PA21
n=391 participants at risk
PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
Sevelamer Carbonate
n=267 participants at risk
Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
15/391 • Number of events 16
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
5.6%
15/267 • Number of events 17
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
32/391 • Number of events 43
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
5.6%
15/267 • Number of events 19
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Nervous system disorders
Headache
|
5.1%
20/391 • Number of events 28
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
3.0%
8/267 • Number of events 19
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.3%
17/391 • Number of events 31
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
6.0%
16/267 • Number of events 28
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
3.8%
15/391 • Number of events 15
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
8.6%
23/267 • Number of events 25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
12.0%
47/391 • Number of events 73
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
10.9%
29/267 • Number of events 47
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Hypertension
|
9.7%
38/391 • Number of events 53
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
7.5%
20/267 • Number of events 29
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
22/391 • Number of events 26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
5.2%
14/267 • Number of events 14
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Vascular disorders
Hypotension
|
4.9%
19/391 • Number of events 37
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
7.9%
21/267 • Number of events 38
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.6%
26/391 • Number of events 39
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
6.0%
16/267 • Number of events 20
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
23/391 • Number of events 26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
4.1%
11/267 • Number of events 12
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set for PA-CL-05B (SS5B). The SS5B consists of all enrolled subjects who had taken at least 1 dose of PA-CL-05B study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.
- Publication restrictions are in place
Restriction type: OTHER